Impact of Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture

A Randomized Controlled Wait-list Pilot Study Examining the Feasibility and Impact of a Combined Psychotherapy and Physiotherapy Group Treatment Program for Survivors of Torture Incarcerated in an Adult Prison in Kurdistan, Iraq

The aim of this study is to assess the impact and feasibility of an interdisciplinary group treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial estimates of treatment effects on symptoms and poor functioning consistent with centralized pain and post-traumatic stress disorder, anxiety, and/or depression. The secondary aim is to assess the feasibility of studying this interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in the Kurdish Sorani language, and to Kurdish participants that present with mental health symptoms, physical complaints, and poor functioning

Study Overview

• Status: Completed
• Conditions: Disability Physical; Pain Syndrome
• Intervention / Treatment: Other: Physiotherapy; Other: Psychotherapy

Detailed Description

The aim of this randomized wait-list controlled pilot study is to assess the impact and feasibility of an interdisciplinary group treatment approach, involving psychotherapy and physiotherapy, with survivors of torture that are incarcerated in a prison in Kurdistan, Iraq. The primary aim is to develop initial estimates of treatment effects on symptoms and poor functioning consistent with centralized pain and post-traumatic stress disorder, anxiety, and/or depression. It is hypothesized that participants in the study will present with statistically significant improvements in some to all measures of symptoms and function. The secondary aim is to assess the feasibility of studying this interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention in a prison, in the Kurdish Sorani language, and to Kurdish participants that present with mental health symptoms, physical complaints, and poor functioning

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan
    • Sulaymaniyah, Kurdistan, Iraq
      • Sulaymaniyah Adult Male Reformatory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Age equal to or greater than 18 years
• Incarcerated in the reformatory where research is conducted
• Native speaker of Sorani, a Kurdish language
• History of torture is reported and documented during the psychotherapy intake
• Presents with symptoms consistent with post-traumatic stress disorder, anxiety, and/or depression evident by a total score of greater than or equal to 1.75 on Hopkins Symptoms Checklist-25 and/or by a total score greater than or equal to 2.5 on the Harvard Trauma Questionnaire Part 4
• Presents with symptoms consistent with centralized pain evident by a score of greater than or equal to 40 on the Central Sensitization Inventory Part A.

Exclusion Criteria:

• Reports he will not remain in the current reformatory for at least 6 months from the onset of the study
• Is unable to make the time commitment required to participate
• Presents with symptoms consistent with a psychiatric condition which makes participation in the study unsafe for himself or others, based on the evaluation by the treating psychotherapist
• Presents with a high risk to self or others which makes participation in the study unsafe for himself or others, based on evaluation by the treating psychotherapist
• Participation is deemed unsafe due to a severe medical condition previously diagnosed by a medical doctor and/or signs/symptoms consistent with a possible medical condition based on the evaluation by the treating physiotherapist, 6.) reports previously receiving treatment by Wchan
• Current substance abuse reported by participant or identified by treating psychotherapist
• Currently receiving mental health services and/or physiotherapy services from other organization
• Reports unresolvable conflict with participant/s enrolled in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Participants randomly assigned to the treatment group will participate in an interdisciplinary treatment program in which local Kurdish psychotherapists and physiotherapists provide a 10-week intervention program. Treatment will consist of group physiotherapy and group psychotherapy	Other: Physiotherapy; Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.; Other: Psychotherapy; Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.
No Intervention: Wait-list group; Participants randomly assigned to the wait-list group will not receive treatment but will participate in outcome data collection for comparison purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Symptom Checklist-25	The HSCL-25 is a 25-question symptom inventory which measures symptoms of anxiety and depression.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Specific Functional Scale	This useful questionnaire can be used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition.	10-weeks
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.	10-weeks
Patient's Global Impression of Change Scale	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment	10-weeks
General Self Efficacy Scale	The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.	10-weeks
Central Sensitization Inventory	This tool was published with the purpose of providing a single self-report instrument that identified symptoms associated with central sensitization and the quantified the degree of those symptoms.	10-weeks
Harvard Trauma Questionnaire Part 4	The Harvard Trauma Questionnaire (HTQ) is a checklist that inquires about a variety of trauma events, as well as the emotional symptoms considered to be uniquely associated with trauma.	10 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jeff A Hartman, DPT, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STU00206726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Still in deliberation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No